title: [Drug registries: post-marketing evaluation of the benefit-risk profile and promotion of appropriateness. The regional point of view].
abstract: Italian Regions and the Italian regulatory agency share a common interest in promoting the appropriateness of drug use, containing drug expenditure and acquiring additional evidence on the effectiveness and safety of drugs. Drug registries can help attaining these objectives. Specifically, the registries implemented in Italy were able to cover the first two objectives, whereas some critical issues were raised on the third one. For instance, the data recorded in the registries are not available at regional level to conduct safety and effectiveness investigations. This is a paradox, when considering that drugs included in the registries have a risk-benefit profile that is only partially defined at the moment of marketing. Currently, researchers and regions can conduct epidemiological research (cohort and case control studies), on the basis of record-linkage procedures, on all drugs prescribed in general practice (which are older drugs with a better defined risk-benefit profile). The expected outcomes of registries should be more clearly defined: when the main aim is to promote appropriateness, the recording of only a very limited amount of data should be required (to avoid a bureaucratic burden on clinicians).The Italian centers of the ENCePP network might play an important role in planning and conducting drug registries: through the presence in the steering committees of the registries, and in conducting epidemiological studies that make the most of this powerful instrument.
authors.affiliation: Direzione Generale Sanità e Politiche Sociali, Regione Emilia-Romagna, Bologna. lumartelli@regione.emilia-romagna.it
authors.forename: Luisa
authors.initials: L
authors.lastname: Martelli
authors.forename: Mauro
authors.initials: M
authors.lastname: Venegoni
mesh_terms: D004345:Drug Industry; D006801:Humans; D007558:Italy; D040541:Marketing; D011358:Product Surveillance, Postmarketing; D012042:Registries; D018570:Risk Assessment